Monitoring of Anti-Malarial Drug resistance by real-time quantitative nucleic acid sequence-based amplification and the impact on TRANSmission of Plasmodium falciparum

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31291803

Enrollment

500

Registered

2007-03-27

Start date

2004-09-01

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated febrile malaria Infections and Infestations Malaria

Interventions

Participants will be randomised to treatment with: 1. Sulphadoxine (25 mg/kg) and pyrimethamine (1.25 mg/kg) as a single dose plus placebo once daily for three days 2.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age six months to ten years 2. Residents of research area, able to come for complete schedule of follow-up 3. Diagnosed with uncomplicated malaria, Plasmodium falciparum or P. falciparum and P. malariae double infection 4. Parasitaemia 1000 to 100,000 P. falciparum P/ul (Giemsa-stained blood smears counted against 200 White Blood Cells (WBC), negative result if 100 parasite negative microscopic fields) 5. Temperature more than 37.5°C and less than 39.5°C, or a history of fever in the previous 24 hours 6. No history of adverse reactions to Sulphadoxine-Pyrimethamine (SP) treatment 7. Understanding of the procedures of the study by parent or guardian and willing to participate (informed consent signed)

Exclusion criteria

Exclusion criteria: 1. General danger signs of severe malaria or Haemoglobin (Hb) count more than 5 gm/dl 2. Severe malnutrition 3. Presence of diseases other than malaria causing febrile conditions 4. Unwilling to participate and sign informed consent forms

Design outcomes

Primary

Measure	Time frame
The following are assessed on days one, two, three, seven, 14 and 28 after initiation of treatment: 1. Resolution of clinical symptoms 2. Presence of malaria parasites by microscopy and molecular techniques 3. Presence of sexual stage malaria parasites by microscopy and molecular techniques 4. Haematological recovery On day 14 the infectiousness to mosquitoes will be assessed by taking a small venous blood sample (2 mL) from children aged less than two years for membrane feeding assays. The blood sample will be offered to locally reared mosquitoes through a membrane. The number of infected mosquitoes and the number of oocysts in infected mosquitoes are primary outcomes for this part of the study.	—

Measure

Time frame

The following are assessed on days one, two, three, seven, 14 and 28 after initiation of treatment: 1. Resolution of clinical symptoms 2. Presence of malaria parasites by microscopy and molecular techniques 3. Presence of sexual stage malaria parasites by microscopy and molecular techniques 4. Haematological recovery On day 14 the infectiousness to mosquitoes will be assessed by taking a small venous blood sample (2 mL) from children aged less than two years for membrane feeding assays. The blood sample will be offered to locally reared mosquitoes through a membrane. The number of infected mosquitoes and the number of oocysts in infected mosquitoes are primary outcomes for this part of the study.

—

Secondary

Measure	Time frame
1. Selection of drug-resistant parasite strains after treatment 2. Transmission of drug-resistant parasite strains after treatment	—

Countries

Kenya, Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026